Follicular extraction punch and method

ABSTRACT

Provided herein is an instrument and method useful to incise in to the skin to a precise depth and at a specific angle with respect to the surface of the skin of a patient, for the extraction of individual follicular groups or individual follicular units. An instrument according to the invention precisely limits the depth of incision, and creates a circular incision around a hair, follicular unit, or follicular cluster in a manner such that no damage occurs to any of the hair shafts.

CROSS-REFERENCE TO RELATED APPLICATION

The present application is a continuation-in-part of U.S applicationSer. No. b 10/795,835 filed Mar. 9, 2004 titled, “Follicular ExtractionDevice and Method” by John P. Cole.

TECHNICAL FIELD

This invention relates generally to surgical instruments useful forextracting live hair follicles from mammalian subjects fortransplantation on other parts of the body of such subjects. Morespecifically, the invention provides a surgical instrument useful forextracting live hair follicles from human skin for transplantation toother portions of the skin, such as the scalp. An instrument accordingto the invention precisely controls the depth to which an incision ismade during the follicular extraction process.

BACKGROUND

The prior art contains numerous examples of instruments useful forextracting live hair follicles from the skin of human subjects, andmethods associated with the use thereof U.S. Pat. No. 4,476,864 teachesa light weight, portable, hand held power actuated hair transplant plugcutting device that is capable of making either simultaneous multiplepunches or a single punch in the scalp of a patient. In the device, asingle shaft member with a removable cutting tip extends through onewall of the housing unit, while a plurality of shaft members withremovable cutting tips extends through the opposite wall of the housingunit. Actuation of a power drive causes rotation of both the singleshaft member and the plurality of shaft members so that only the singlecutting device is needed to make all of the punches required for thehair transplant operation. Tools are also provided for placing andremoving disposable cutting tips on and from the shaft members. U.S.Pat. No. 5,507,765 describes a punch-type surgical instrument for skinincision along a closed line, such as a substantially elliptical line,that includes a handle, a blade unit and a means for attaching thehandle to the blade unit in a way which achieves high stability betweenthe handle and blade it and which allows the two parts to be made asones easily connectable to and dis-connectable from one another. Theblade unit may be made and furnished in different sizes to cause theinstrument to be one selectably variable in size. U.S. Pat. No.5,578,054 sets forth a method for transplanting hair, which methodcomprises: a) inserting an instrument having a shaft with a proximalend, a sharpened distal end forming a blade thereon, and a longitudinalaxis extending between the proximal end and the distal end, into theskin to a pre-selected depth as determined by a stop disposed along theshaft to form an incision, wherein the blade is normal to thelongitudinal axis of the shaft, and wherein the stop prevents the bladefrom extending beyond about 5 mm into the scalp, and wherein thedistance between the blade and the stop is adjusted before inserting theblade; b) removing the instrument from the skin; and c) placing a graftof skin having at least one hair into the incision. U.S. Pat. No.5,766,177 provides a rongeur which comprises: a) a body having a distalend, a tubular portion and a proximal end, wherein the body at thedistal end includes an elongated member terminating in an anvil and atthe proximal end terminating in handle means; b) a tubular cuttingmember, wherein the cutting member is movable within and guided by thetubular portion and extending beyond the body at the proximal end; andc) a means for actuating the cutting member to cut bodily materialplaced between the anvil and the distal end of the cutting member. U.S.Pat. No. 5,792,169 discloses an instrument for placement of hair graftsin the tissue of a patient, comprising: a) a first plate comprising abase member having a number of first bores passing therethrough, and anumber of hollow first catheters extending therefrom and aligned withthe first bores; b) a second plate comprising a base having a number offirst spikes extending therefrom, the spikes arranged and sized forlocation within the first catheters; c) a third plate having a base witha number of second bores passing therethrough and a number of hollowsecond catheters extending therefrom and aligned with the second bores,the second catheters sized for location within the first catheters; andd) a fourth plate having a base, with a number of second spikesextending therefrom, wherein the second spikes are arranged and sizedfor location within the second catheters. U.S. Pat No. 5,817,120 teachesan instrument for implanting hair grafts into a patient's scalp,comprising: a) an elongate housing adapted to be manipulated by asurgeon during implanting of the hair grafts, wherein the elongatehousing has a throughbore extending at least partway therealong from afirst end thereof, and having a slot defining a slotted loading positionadjacent to the throughbore for loading hair grafts into the instrument;b) a cutting device affixed to the first end of the elongate housing bywhich the surgeon may make an incision in the patient's scalp, intowhich a hair graft is to be implanted; and c) an implanting member,disposed axially movably within the throughbore of the elongate housing,wherein the implanting member includes a forwardly projecting finger.The implanting member is movable from a first position in which thefinger is positioned adjacent to the slotted loading position so as tobe able to load a hair graft, to a second position in which a loadedhair graft is bounded between the finger and the cutting device, and toa third position in which the finger extends beyond the cutting device.U.S. Pat. No. 5,895,403 describes a surgical cutting tool with vacuumclearance capability, comprising a length of cylindrical surgical steelhaving an axial bore therethrough, a proximal end cutting tipterminating in a cutting edge, and a distal end. The axial bore has afirst inside diameter at the cutting edge, a second inside diametergreater than the first inside diameter forming a first relief near thecutting edge, and a third inside diameter greater than the second insidediameter forming a second relief upstream of the first relief. As vacuumis applied at the distal end of the tool, tissue plugs cut at thecutting edge pass easily through the first and second reliefs to exitthe axial bore.

However, of all the prior art, none has thus far provided an instrumentthrough the use of which the precise depth of incision is repeatedly andprecisely controlled to result in the vast majority of folliclesextracted to continue to furnish hair at the new site to which they aretransplanted. The present invention provides such an instrument, whichis also simplistic in design and easy to use by the skilledpractitioner.

SUMMARY OF THE INVENTION

The present invention provides an instrument useful for extracting livehair follicles from mammalian skin tissue, which device comprises a mainbody portion having a first end portion, a second end portion, and alongest length dimension. The main body portion further comprises afirst bore centrally disposed therethrough, wherein the axis of thefirst bore runs parallel to the longest length dimension of the mainbody portion. The first bore comprises an inner surface within the mainbody. There is a nipple end portion having a first end portion and a tipportion, which nipple end portion further includes a second borecentrally disposed therethrough. The first end portion of the nipple endportion is attached to the second end portion of the main body portion,and the second bore comprises an inner surface within the nipple end.There is a tubular punch means having a first end portion and a sharpend portion. In one preferred form of the invention, the tubular punchexists substantially in the form of a hollow cylinder having an interiorspace and an outer diameter, wherein the outer diameter of the tubularpunch means is slightly larger than the inner diameter of the secondbore, and wherein the tubular punch means is slidably disposed withinthe second bore, so as to provide a slight interference fit. There is astabilizer means disposed within the first bore and in contact with thefirst end portion of the tubular punch means. There is an adjustmentscrew comprising a threaded outer surface and an end. The adjustmentscrew is disposed within the first bore such that its threaded outersurface is in contact with the inner surface within the main body. Theend of the adjustment screw is in contact with the stabilizer. Accordingto one preferred form of the invention, the stabilizer includes a thirdbore disposed therethrough that is adapted to receive the first endportion of the tubular punch means. In one embodiment, the first endportion of the tubular punch means is disposed within the third borethrough the stabilizer means such that the stabilizer means and thetubular punch means are both slidably disposed as a unit within thefirst bore and the second bore respectively. In one preferred form ofthe invention, the adjustment screw includes a head portion and an endportion, and further comprises a fourth bore centrally disposed throughits length. The fourth bore may extend from the head portion to the endportion. Thus, in one form of the invention, the interior space withinthe tubular punch means is in fluid communication with the fourth boredisposed within the adjustment screw.

Yet another embodiment of the invention provides that the first boreextends from the first end portion to the second end portion of the mainbody portion. In yet another embodiment of the invention the main bodyportion is substantially cylindrically shaped. In yet another embodimentof the invention the tubular punch means has an outer surface, and theouter surface of the tubular punch means is in contact with the innersurface of the second bore disposed within the nipple end portion. Inyet another embodiment of the invention the nipple end portion issubstantially cylindrically shaped. In yet another embodiment of theinvention the first bore and the second bore have the same diameter. Inyet another embodiment of the invention the diameter of the second boreis less than the diameter of the first bore. In yet another embodimentof the invention the diameter of the second bore is greater than thediameter of the first bore. In yet another embodiment of the inventionthe outer diameter of the tubular punch means is smaller than the innerdiameter of the second bore. In yet another embodiment of the inventionthe nipple end and main body comprise a single, constrict, and are asingle article comprising a plastic, which is made using an injectionmolding process. In yet another embodiment of the invention the sharpend of the tubular punch means comprises a beveled edge. In yet anotherembodiment of the invention the stabilizer means is comprised of anelastomeric material selected from the group consisting of: polyolefinhomopolymers, polyolefin copolymers, thermoplastic vulcanizates, andthermoset elastomers. In yet another embodiment of the invention thetubular punch means is metallic. In yet another embodiment of theinvention the tubular punch means further includes an inner diameterwhich is substantially uniform along the entire length of the tubularpunch means. In one preferred form of the invention the inner diameterof the tubular punch means is any diameter in the range of between about0.5 millimeters and about 4.5 millimeters. In one preferred embodimentof the invention the nipple end portion comprises a flat surface whichis adapted to contact the skin of a patient, and the total surface areaof the nipple end which contacts the patient is in the range of betweenabout 5 square millimeters and about 25 square millimeters.

In a more general sense, the invention provides an instrument useful forextracting live hair follicles from mammalian skin tissue, which devicecomprises: a nipple end portion having a first end portion and a tipportion. The nipple end portion has a longest length dimension andfurther includes a bore disposed therethrough whose axis is parallel tothe longest length dimension. The bore comprises an inner surface withinthe nipple end. There is a tubular punch means which existssubstantially in the form of a hollow cylinder having two open ends, aninterior space, and an outer diameter not exceeding about 5.0millimeters. At least one end of the tubular punch means is a cuttingend which is capable of piercing the skin. The tubular punch meansfurther includes an inner diameter between about 0.5 millimeters and 4.5millimeters, which is substantially uniform along the entire length ofthe tubular punch means. The tubular punch means is slidably disposedwithin the bore such that its cutting end is capable of coinciding withthe tip portion of the nipple end portion when the tubular punch meansdoes not protrude outward from the tip portion. There is a means foradjusting the position of the tubular punch means within the bore,including control of the amount which the cutting end protrudes from thetip portion of the nipple end portion. The nipple end portion maycomprise a flat surface which is adapted to contact the skin of apatient, wherein the total surface area of the nipple end which contactsthe patient is in the range of between about 5 and about 25 squaremillimeters. According to one preferred form of the invention, the meansfor adjusting the position of the tubular punch means within the borecomprises a threaded screw having an end portion which is in effectivemechanical contact with the tubular punch means, and a stationaryportion capable of engaging with the threads on the screw, wherein thestationary portion is in effective mechanical contact with the nippleend portion. In one form of the invention, such means includes the mainbody portion 3, adjustment screw 15, and stabilizer 11, as describedelsewhere herein.

The invention further provides a process for extracting a live hairfollicle from a mammalian subject comprising the steps of: a) providinga tubular punch means which exists substantially in the form of a hollowcylinder having and axis, a first open end, a second open end, aninterior space, and an outer diameter not exceeding about 2.0millimeters, wherein the first end of the tubular punch means is acutting end which is capable of piercing the skin; b) contacting thecutting end to the skin of a mammalian subject, such that a hair on theskin of the mammalian subject is disposed within the interior space, andsuch that the axis of the cylinder is disposed at a first angle withrespect to the surface of the skin of the subject, wherein the firstangle is between about 85 degrees and 95 degrees; c) causing the cuttingend to penetrate the skin of the subject to a depth of at least 0.05millimeters but no greater than about 0.3 millimeters; d) tilting thetubular punch means so that it is disposed at a second angle withrespect to the surface of the skin of the subject, which second angle isany angle between about 20 degrees and about 70 degrees; e) causing thecutting end to further penetrate the skin of the subject to a depth ofat least 1 millimeter but no greater than about 7 millimeters (with anaverage of about 4.15 mm) while maintaining the tubular punch means atthe second angle with respect to the surface of the skin of the subjectand while maintaining the hair within the interior space so as to causeto follicle within which the hair grows to be disposed within theinterior space; and f) removing the follicle from the subject. In apreferred process according to the invention, the first angle is about90 degrees and wherein the second angle is about 56 degrees or thecorresponding acute angle of hair growth to the surface of the skin.According to one preferred process according to the invention, the stepof removing the follicle from the subject comprises applying a vacuum tothe second end of the tubular punch means, or may be accomplished bycutting the follicle from the. subject using a sharp instrument, such asa scalpel or modified scalpel, which is available from the instantinventor.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 a shows an exploded perspective view of the various components ofa tool according to the invention;

FIG. 1 b shows an overhead view of the body portion 3 of a toolaccording to one preferred form of the invention;

FIG. 1 c shows a perspective view of a tabular punch means element of atool according to the invention;

FIG. 1 d shows an end view of the tubular punch means element of theinvention;

FIG. 1 e shows an end view of the main body portion of an instrumentaccording to the invention as viewed from the nipple end perspective;

FIG. 1 f shows a side perspective view of a tubular punch meansaccording to an alternate form of the invention; FIG. 1 g shows a sideperspective view of a tubular punch means according to an alternate formof the invention;

FIG. 2 shows a cutaway view of a tool according to the invention in itsassembled form;

FIG. 3 shows a cutaway view of a tool according to an alternate form ofthe invention in its assembled form;

FIG. 4 shows a section of skin containing a hair follicle in contactwith a portion of a tool according to the invention;

FIG. 5 shows a section of skin containing a hair follicle in contactwith a portion of a tool according to the invention;

FIG. 6 shows a section of skin containing a hair follicle in contactwith a portion of a tool according to the invention;

FIG. 7 shows a section of skin containing a hair follicle in contactwith a portion of a tool according to the invention; and

FIG. 8 shows a section of skin containing a hair follicle in contactwith a portion of a tool according to the invention.

DETAILED DESCRIPTION

Referring to the drawings and initially to FIG. 1 a there is shown anexploded perspective view of the various components of a tool accordingto the invention, including the main body portion 3, tubular punch means9, stabilizer means 1 l, and adjusting screw 15. The main body portion 3in a preferred form of the invention is a construct which issubstantially cylindrically shaped, having an open first end portion 37and a second end portion 39. The main body portion 3 further includes abore 5 centrally disposed therewithin along its longest lengthdimension, which bore in one preferred form of the invention extendsfrom the first end portion 37 to the second end portion 39. The walls ofthe main body portion 3 at the second end portion 39 are tapered inwardstowards the axis of the bore 5, and coextensively intersect a nipple endportion 19, which nipple end portion 19 is substantially cylindricallyshaped and includes a first end portion 41 and a tip portion 43. Such anarrangement provides for the second end portion 39 of the main bodyportion 3 to be attached to the nipple end 19 at the first end portion41 of the nipple end 19. The nipple end 19 includes a bore 21 centrallydisposed therewith along its longest length dimension, which boreextends from the first end portion 41 of the nipple end 19 to the tipportion 43 of the nipple end 19, and the bore 5 and bore 21 are thus influid communication with one another in a main body portion 3 providedin accordance with a preferred form of the invention. Further, the bore5 is open to the ambient surroundings at the first end portion 37, andthe bore 21 is open to the ambient surroundings at the tip portion 43.The main body portion is thus reminiscent of the body portion of commonpolyolefin syringes which are in common use in the medical arts.According to a preferred form of the invention, the main body portion 3and the nipple end 19 are both elements of a single common constructionprovided for example, by an injection molding process. The length of thenipple end 19 is preferably in the range of between about 0.03millimeters and about 10 millimeters, with a preferred length of about 6millimeters. When an instrument according to the invention is fabricatedfrom a plastic material, it is preferred that the bore 21 is slightlysmaller than the outside diameter of the tubular punch means 9, topreclude the tubular punch means from motion induced either by thesurgeon moving the instrument of the invention around and about, or theinfluences of gravity. In one form of the invention when the nipple end19 is fabricated from a polyolefin, it is preferred that the bore 21within the nipple end 19 is at least about 0.1 millimeter smaller thanthe outside diameter of the tubular punch means 9.

The main body portion 3 is preferably comprised of a translucentmaterial, such as a thermoplastic polyolefin such as homopolymers ofpolypropylene or polyethylene, including copolymers of the foregoingwith any C.sub.1-6 olefinic monomer, as such materials are well known tothose in the polymer arts. However, other materials of constructionincluding glass, various metals such as stainless steels, etc. are alsosuitable materials from which the main body portion of a tool accordingto the invention may be constructed. The main body portion 3 is alsopreferably provided with graduation markings on its outer surface, toassist in setting the depth of the tubular punch means 9 as is explainedlater in this specification. The main body portion 3 in a preferred formof the invention also optionally includes a plurality of gripping means7 disposed at the first end portion 37 of the main body portion 3. Theseoptional gripping means 7 in one form of the invention are flanges whichextend perpendicularly with respect to the axis of the bore 5 andoverall length dimension of the main body portion 3.

FIG. 1 b shows an overhead view of the body portion 3 of a toolaccording to one preferred form of the invention, as viewed from thefirst end portion 37 looking down into the bore 5 and showing therespective locations of the gripping means 7, the bore 5, and thethickness W of the wall portion of the main body 3 itself. Also visiblein this view is the bore 21 of the nipple end at the far end of the bore5.

FIG. 1 c shows a perspective view of a tubular punch means element 9 ofa tool according to the invention. The tubular punch means is a hollowtube, preferably comprised of a metal or metal alloy such as stainlesssteel or titanium. However, any metal or alloy recognized as beinguseful for the manufacture of surgical equipment may be used as a rawmaterial from which the tubular punch means 9 is fabricated, includingvarious different grades of stainless steels, and protective coatingssubsequently applied thereto, such as titanium, zirconium, coatings,etc., whose use is well known in the art. The tubular punch means 9includes a first end portion 35 and a sharp end portion 33. The sharpend portion in one preferred form of the invention includes a bevel 45which is coextensively disposed about the sharp end portion, whichconstitutes a cutting edge. The tubular punch means 9 in its simplestform a hollow tube which is shaped in the form of a hollow cylinderhaving an open top portion, an open bottom portion, and a wall portion,with a bore disposed longitudinally therethrough. Preferably, the insidediameter of the tubular punch means 9 is any diameter in the rangebetween about 0.5 millimeters to about 4.5 millimeters, and preferablythe outside diameter of the tubular punch means 9 is about 0.2millimeters to about 0.3 millimeters greater than the inside diameter.

FIG. 1 d shows an end view of the tubular punch means 9, and FIG. 1 eshows an end view of the main body portion of an instrument according tothe invention as viewed from the nipple end perspective, and therespective locations of the nipple end 19 and the bore extendingtherethrough 21. The thickness of the wall portion W of the main body 3is also shown. In this FIG. 1 e it can be seen that the portion of thenipple end which is intended to contact the skin of the patient isshaped like a donut; stated another way, the portion of the nipple endwhich contacts the patients' skin is in one preferred form of theinvention a substantially planar surface that is bounded by twoconcentric circles in a preferred form of the invention. Preferably, thetotal amount of surface area which contacts the skin is in the range ofbetween about 5 square millimeters and about 25 square millimeters, andis obtained by subtracting the surface area of the circle represented bythe bore 21 from the surface area of a circular area having the diameterof the nipple end 19, when the nipple end is circular in cross section.

FIG. 1 f shows a side perspective view of a tubular punch means 9according to an alternate form of the invention. In this embodiment, thesharp end 33 of the tubular punch means 9 is shown to be angled. Thevalue of B/2 is about 0.5 millimeters; D is about 1 millimeter, B isabout 0.32 millimeters, and the shaded area represents that section ofthe tubular punch means which preferably comprises titanium, or atitanium coating.

FIG. 1 g shows a side perspective view of a tubular punch meansaccording to an alternate form of the invention. In this embodiment, Ais about 0.58 millimeters; B is about 1 millimeter; C is about 1.15millimeters; and the angle theta is about 60 degrees. However, any angleof theta in the range of between about 30 degrees and 90 degrees iswithin the scope of the present invention.

There is a stabilizer means 11 which in one form of the invention is asolid cylindrical construct made preferably from an elastomericsubstance, such as a molded rubber, wherein the stabilizer means 11 hasan outside diameter which is slightly greater than or approximately thesame size as the diameter of bore 5, to enable the stabilizer means 11to reside within the bore 5 in a sufficiently snug manner so as toenable the stabilizer means to be retained within the bore 5 in theevent that the main body 3 containing the stabilizer means 11 within itsbore 5 is inverted and the stabilizer means is subject to normalgravitational forces. In another embodiment, the stabilizer means 11includes a bore 13 whose axis coincides substantially with the axis ofthe stabilizer means itself. In such an embodiment, the diameter of thebore 13 is preferably slightly smaller than the outer diameter of thetubular punch means 9 (the diameter of which is uniform along itslength), so as to enable the first end portion 35 of the tubular punchmeans 9 to be retained within the bore 13 within the stabilizer means 11by a snug interference fit caused to exist by the slight expansion ofthe elastomeric stabilizer means 11 from the insertion of the tubularpunch means in to the bore 11. The bore 13 is preferably centrallydisposed within the stabilizer so that the punch means 9 is maintainedin a central axis. The stabilizer 11 limits movement of the punch means9 in a lateral direction within bore 5, and maintains proper alignmentof punch means 9 with the angle and direction of hair growth. Thestabilizer may be comprised of: polyolefin homopolymers, such aspolypropylene or polyethylene; polyolefin copolymers, includingethylene-propylene copolymers, propylene butene copolymers, andpropylene-octene copolymers; thermoplastic vulcanizates; and thermosetelastomers.

In FIG. 1 a there is also shown an adjustment screw 15, which includesthreads on its outer surface, which are of such dimension to cause themto effectively mate with the inner surface of the bore 5 of the bodyportion 3. The inner wall of the bore 5 of the main body portion 3 mayor may not include threads. Thus, in constructing a tool according tothe invention, the adjustment screw 15 is inserted into the bore 5 andthe adjustment screw 15 is rotated to cause it to reside at a desireddepth or location within the bore 5. The adjustment screw 15 includes ahead portion 17 which is convenient for a user of an instrumentaccording to the invention to grasp. In one embodiment, the adjustmentscrew 15 may be coated with tape to improve its contact with bore 5 andto reduce slippage.

FIG. 2 shows an assembled tool 10 according to the invention andillustrating the respective positions of the various elements of theinvention including the adjustment screw 15, within the main body 3. Thetubular punch means 9 is shown disposed within the bore 21, whose innerdiameter is slightly larger than the outside diameter of the tubularpunch means 9 so as to enable the nipple end 19 to act as a bearing formovement of the tubular punch means laterally within the bore 21.Stabilizer means 11 is shown disposed between first end portion 35 ofthe tubular punch and end 39 of the body portion 3 such that it iscoextensively disposed about tubular punch 9 at the end of tubular punch9 closest to end 39 but not in contact with stabilizer 11. Under such anarrangement, turning the adjustment screw inwards into the bore 5 of themain body portion causes the sharp end 33 of the tubular punch means toprotrude from the tip portion 43 of the nipple end 19 in an amountproportional to the amount the adjustment screw enters the bore 5 byvirtue of its being rotated.

FIG. 3 shows an assembled tool 10 according to an alternate form of theinvention and illustrating the respective positions of its variouselements including the adjustment screw 15, within the main body 3. Inthis embodiment, the adjustment screw includes a bore 23 disposedthrough its center along its entire length, providing a hole 25 to existat the top of the head portion 17. The head portion 17 can take on avariety of shapes, dimensions, and surface coatings. According to onepreferred form of the invention, the width of the head portion 17 isgreater than about 9 millimeters. The tubular punch means 9 is showndisposed within the bore 21, whose inner diameter is slightly largerthan the outside diameter of the tubular punch means 9 so as to enablethe nipple end 19 to act as a guide for movement of the tubular punchmeans 9 within the bore 21. Stabilizer means 11 is shown disposedbetween the first end portion 39 of the tubular punch means 9 and thesecond end portion 39 of the main body portion 3. In this embodiment,the stabilizer means 11 includes a bore 13 as shown in FIG. 1, in whichis disposed a section of the tubular punch means. Thus, the interiorspace within the tubular punch means in this embodiment is in fluidcommunication with the hollow interior space within the bore 23, whichalso means that the space within the hole 25 is in fluid communicationwith the most distal (tip) portion of the tubular punch means 9. Thisprovision enables a vacuum source to be selectively applied to the holeat 25 to assist in the successful extraction of a follicle, blood,fluid, or serum through use of the device 10. Again, turning theadjustment screw inwards into the bore of the main body portion 3 causesthe sharp end 33 of the tubular punch means to protrude from the tipportion 43 of the nipple end 19 in an amount proportional to the amountthe adjustment screw enters the bore 5 by virtue of its being rotated.

The assembly of an instrument according to the invention is astraightforward undertaking First, the main body portion 3 is provided.Next, the tubular punch means 9 and stabilizer means 11 are caused toreside at their earlier-specified locations within the bores 21 and 5respectively. This may be accomplished by first placing the tubularpunch means into the bore 21, and separately placing the stabilizermeans 11 into the opening at the first end portion 37 of the main bodyportion and forcing it downwards (such as with a rigid rod such as apencil, screwdriver, etc.) into the bore 5 until the stabilizer means 11comes into contact with the tubular punch means. Alternatively, asmentioned above, the stabilizer means 11 itself may be provided with abore 13 into which the dull end of the tubular punch means 9 is firstpartially inserted, thus forming a sub-assembly consisting of thetubular punch means 9 and stabilizer means 11. This sub-assembly maythen be placed into the opening at the first end portion 37 of the mainbody portion 3 with the tubular punch means 9 end of the sub-assemblybeing inserted first and forced downwards, taking care that the tubularpunch means enters the bore 21 as the sub-assembly approaches the secondend portion 39 of the main body 3. Subsequent to the placement of thetubular punch means 9 and stabilizer means 11 at their respectivelocations within the main body portion, the adjustment screw 15 is nextplaced into the bore 5, preferably by turning the screw head 17 or otherconvenient grasping means for manipulating the rotational motion of theadjustment screw. The adjustment screw is caused to enter the bore to adepth at which it just first touches the stabilizer means, and then careis taken to continue slowly admitting more of the screw into the bore soas to cause the sharp end portion of the tubular punch means 9 to bejust flush with the distal end of the nipple end 19. In accordance withthe use of an instrument according to the invention, it will be foundnecessary at times to precisely adjust the distance or amount that theend portion of the tubular punch means 9 protrudes from the end of thenipple end 19, as it is shown to do so a distance denoted D in FIG. 7,as later explained. Turning the adjustment screw 15 is thus useful inaccomplishing the task of forcing the tubular punch means 9 out of thenipple end 19 a precise desired amount, as is necessary to providestatistically large proportions of hair grafts having a high probabilityof survival, which may often be greater than such numbers provided bymany, if not all, devices of the prior art having similar intendedfunctions. This action is assisted using the presence of graduationmarks disposed along the translucent main body 3 as a guide. Thegraduation marks may be printed on through the use of inks or etchings,or may be milled or ground into the body 3 itself.

Although the stabilizer means 11 is shown in one location within thebore 5 in FIG. 1 a and at another location in FIG. 3, and is thusmoveable within the bore 5, it is within the scope of the presentinvention that the stabilizer means 11 is disposed in a stationaryposition within the bore, at any location within the bore 5. Accordingto one preferred form of the invention, the stabilizer means 11 isbottomed out within the bore 5 at a position which represents itsfurthest possible travel position against the nipple end portion 19. Inaddition, it is within the scope of the present invention that thetubular punch means 9 is slidably disposed with respect to thestabilizer means 11, i.e., in one embodiment the tubular punch means maymove with respect to the stabilizer means 11 by motion through the bore13, and in another embodiment the tubular punch means 9 is not moveablewith respect to the stabilizer means 11, especially in the embodimentwhen the stabilizer means 11 is not fixed in a stationary positionwithin the bore 5. It is especially preferred that the user be able tovisually observe the first end portion 35 of the tubular punch means 9within the bore 5, and towards this end it is preferred that thematerial from which the main body portion 3 is comprised to be visuallytranslucent or to comprise a window to enable such observation. In FIG.3 is shown the first end portion 35 of the tubular punch means 9 incontact with the end 47 of the adjusting screw 15. In one embodiment thediameter of the bore 23 through the adjustment screw is larger than theouter diameter of the tubular punch means 9. In another embodiment, thediameter of the bore 23 through the adjustment screw is smaller than theouter diameter of the tubular punch means 9. In another embodiment, thediameter of the bore 23 through the adjustment screw is substantiallyequivalent to the outer diameter of the tubular punch means 9. Inanother embodiment, the diameter of the bore 23 through the adjustmentscrew is larger than the outer diameter of the tubular punch means 9 andthe tubular punch means 9 protrudes above the surface of the stabilizermeans 11 only slightly, so as to enable the stabilizer means 11 tofunction as a gasket in providing a tight seal between the inner spacewithin the tubular punch means 9 and the bore 23. The end portion 35 ofthe tubular punch means may be disposed within the bore 23.

FIG. 4 shows a section of skin 31 containing a hair follicle 27 with ahair 29 disposed therein, wherein the surface of the skin is in contactwith the tubular punch means 9 portion of a tool according to theinvention. This FIG. 4 illustrates the first step in illustratinggenerally a process for extracting a live hair follicle from the skinusing an instrument according to the invention as a tool. In this firststep, which may be called the initial alignment step, the tubular punchmenu 9, after its having been caused to protrude from the nipple end 19of an instrument according to the invention a pre-determined amount, iscontacted with the skin at an angle alpha of approximately. 90 degreeswith respect to the skin's surface, over the location at which a hair 29is growing out of the skin while attempting to keep the hair centered inthe bore of the tubular punch means 9. This angle is preferably 90degrees to the surface of the skin, but may be any angle between about80 and 100 degrees. An initial incision substantially perpendicular tothe skin may result in a smaller incision surface area and may reducethe overall surface area of scar tissue.

Next, as shown in FIG. 5, the sharp end portion 33 of the tubular punchmeans 9 is caused to penetrate the skin over the location at which ahair 29 is growing, an amount equal to the distance denoted D, while theangle alpha with which the tubular punch means 9 is disposed withrespect to the skin's surface is maintained at an angle between about 80and about 100 degrees with an angle alpha of 90 degrees being especiallypreferred. The distance D is preferably any distance between about 0.05millimeters and 0.5 millimeters with a depth D of about 0.2 millimeterstypically being most preferred when proceeding according to this initialpenetration step of the instant method. After the initial penetrationstep has been accomplished and the sharp end of the tubular punch means9 has penetrated the skin to the desired depth within the above range,the device of the invention, in the hands of a skilled surgeon, is nextprecisely angled by the surgeon while still at depth D to an angle oforientation such as that shown in FIG. 6 as alpha-2, and the tubularpunch means is inserted into the dermis to a second depth D2 while thetubular punch means 9 is maintained at the precise depth angle denotedas alpha-2 during the entire timespan of the insertion to the new depthD2, while ensuring that the incision is along the same axis as the hairgrowth. All follicular clusters that consist of more than one hair willhave splaying or widening of the distance between the hairs as the hairsenter the skin surface, which is similar to a vase containing a clusteror plurality of stemmed flowers, in which the clusters of flowersnarrows at the neck of the vase, which corresponds to the follicularcanal for multiple hairs comprising a follicular group. Like a vase offlowers, the distance between stems (or the hairs) becomes more randomand wider as the flowers (or hairs) proceed to their maximal depth. Atubular punch means of one millimeter diameter will not fit around allthe hairs if the splaying is great or if the number of hairs in thefollicular groups is large. Therefore, it is very important to limit thedepth of the incision. Making an incision so deep that the hairs withinthe follicular cluster no longer fit inside the inside diameter of thetubular punch means 9 will result in cutting one or more hair folliclesinto two segments or a “transection”.

The insertion of the tubular punch means 9 into the skin may occur byapplying a straight pressure to the device as a whole and isaccomplished by the sharp end of the tubular punch means 9 cutting itsway through the skin; alternatively, the entire device may be rotated,oscillated and/or moved in a reciprocating fashion or some combinationthereof while under slight force by the surgeon during the insertion.The depth D2 may be any depth in the range of about 2 millimeters toabout 7 millimeters, with the preferred depth of D2 being typicallyabout 3.8 millimeters. Once the critical depth D2 has been reached, thefollicles may be removed by gently tugging on the top of the folliclesso that the follicular group is removed in its entirety or thefollicular cluster is teased out, using sharp dissection with a surgicalneedle, a modified scalpel available from the present inventor, or ahair extractor forecep available from the present inventor. Applicationof a vacuum to hole 25 is instrumental in assisting removal of folliclesand/or follicular groups. The critical depth is important to the successof a procedure according to the invention because if the depth is tooshallow, it will be very difficult to remove the follicles. On the otherhand, if the depth is too deep, the risk of follicular damage includingtransection becomes detrimentally significant.

Owing to variance amongst individuals within a race or class ofmammalian species with respect to the ultimate average depth of theirhair follicles and root below the surface of the skin, and alsodepending on the location of the hair follicles on the body, I havediscovered that by precisely controlling the amount which the tubularpunch means 9 protrudes from the nipple end 19 of the device of thisinvention, that great reproducibility of consistency of hair folliclesextracted having identical depths is now made possible through the useof my invention. Once the average critical depth of the follicles for aparticular individual has been determined, this consistency afforded bymy invention allows for the vast majority of follicles extracted usingmy device and method to survive as fertile potential implants fortransplantation to other parts of the same subject's dermal areas, witha success rate exceeding 90% in most cases being readily achievable,which represents a major advance in this art.

In FIG. 7 is shown a section of skin 31 containing a hair follicle 27 incontact with a portion of an instrument according to the invention. Inthis figure, the initial penetration step has been accomplished, and thesharp end of the tubular punch means 9 has penetrated the skin to thedesired depth within the range specified earlier for the depth D. Thisfigure illustrates how the nipple end acts as a stop, in limiting thedepth of penetration allowed by the tubular punch means into the skin.The depth of penetration is limited to the amount that the tubular punchmeans 9 protrudes from the nipple end 19, which is readily controllableby the surgeon by adjusting the adjustment screw 15. In this FIG. 7 isshown the first end portion 35 of the tubular punch means 9 in contactwith the end 47 of the adjusting screw 15.

In FIG. 8 is shown a section of skin 31 containing a hair follicle 27 incontact with a portion of an instrument according to the invention. Inthis figure, the initial penetration step has been accomplished, and thesharp end of the tubular punch means 9 has penetrated the skin to thedesired depth within the range specified earlier for the depth D2. Thisfigure also illustrates how the nipple end acts as a stop, in limitingthe depth of penetration allowed by the tubular punch means into theskin. The depth of penetration is again seen to be limited to the amountthat the tubular punch means 9 protrudes from the nipple end 19, whichis readily controllable by the surgeon by adjusting the adjustment screw15.

In one particularly preferred embodiment, the length of the tubularpunch means 9 is 2.5 centimeters in length. The width of the adjustmentscrew 15 is about 4.5 millimeters and the length of the adjustment screw15 is about 10 centimeters, and the width of the head portion 17 isabout 9 millimeters. However, the head portion 17 could be much widerand have a variety of geometrical shapes, and the present inventionincludes embodiments wherein the adjustment screw 15 has any length,while enabling the device as a whole to retain its intendedfunctionality. In one form of the invention, the nipple end portion 19is tapered, and has an outside diameter of about 4.38 millimeters at thetop which tapers down to about 4.22 millimeters at the bottom, with anoverall length of about 8 millimeters. However, the present inventionincludes embodiments wherein the nipple end portion is of any length,while enabling the device as a whole to retain its intendedfunctionality. In one preferred form of the invention, the main bodyportion 3 is about 8 centimeters long, and has a width between about6.55 millimeters and 6.67 millimeters. However, the present inventionincludes embodiments wherein the main body portion 3 is of anydimensions, wider, narrower, thinner, thicker, longer or shorter, asprescribed herein, provided that the functionality of the device asspecified herein is maintained.

In a particular embodiment, extraction sites and/or tubular punch 9 maybe treated with surgical lubricant to decrease friction upon incisioninto the skin. According to a particular embodiment, surgical lubricantmay minimize trauma to the hair follicle and may reduce scarring. In aparticular embodiment, an antibiotic ointment may be applied to theincision site to accelerate healing, to reduce the risk of infection andto minimize scarring. After an application of antibiotic ointment, theextraction sites may be treated with a topical steroid to reduce therisk of inflammation and post-inflammatory hypo-pigmentation. Treatmentwith a topical steroid may also reduce the risk of scarring.

Consideration must be given to the fact that although this invention hasbeen described and disclosed in relation to certain preferredembodiments, obvious equivalent modifications and alterations thereofwill become apparent to one of ordinary skill in this art upon readingand understanding this specification and the claims appended hereto. Thepresent invention further includes all possible combinations of thefeatures recited in the specification and/or any one of the variousclaims appended hereto with the features recited elsewhere in thespecification and/or in any one or more of each of the remaining claims.Accordingly, the presently disclosed invention is intended to cover allsuch modifications, alterations, and combinations.

1-32. (canceled)
 33. A process comprising: providing a tubular punchmeans which exists substantially in the form of a hollow cylinder havingan axis, a first open end, a second open end, an interior space, and anouter diameter not exceeding about 5.0 millimeters, wherein said firstend of said tubular punch means is a cutting end which is capable ofpiercing the skin; contacting said cutting end to the skin of amammalian subject, such that a hair on the skin of said mammaliansubject is disposed within said interior space, and such that the axisof said cylinder is disposed at a first angle with respect to thesurface of the skin of said subject, wherein said first angle is betweenabout 85 degrees and 95 degrees; causing said cutting end to penetratethe skin of said subject to a depth of at least 0.05 millimeters but nogreater than about 0.3 millimeters; tilting said tubular punch means sothat it is disposed at a second angle with respect to the surface of theskin of said subject, which second angle is selected from the groupconsisting of: any angle between about 20 degrees and about 70 degreesand the angle of hair growth; causing said cutting end to furtherpenetrate the skin of said subject to a depth of at least 2 millimetersbut no greater than about 7 millimeters while maintaining said tubularpunch means at said second angle with respect to the surface of the skinof said subject and while maintaining said hair within said interiorspace, so as to cause to follicle(s) within which said hair grows to bedisposed within said interior space; and removing said follicle fromsaid subject.
 34. A process according to claim 33 wherein said firstangle is about 90 degrees and wherein said second angle is about 56degrees.
 35. A process according to claim 33 wherein said removing thefollicle from the subject comprises applying a vacuum to said second endof said tubular punch means.
 36. A process according to claim 33 whereinsaid removing the follicle from the subject comprises cutting saidfollicle from said subject.
 37. A process according to claim 33 whereinsaid second angle coincides with the angle of growth of said hair withrespect to the surface of the skin of said subject.
 38. A methodcomprising: contacting a surface of skin at a first angle with respectto the surface of the skin using a tubular punch; making a firstincision about a hair follicle into the surface of skin using thetubular punch; penetrating the skin with the tubular punch to a firstdepth of between about 0.05 millimeters and 0.3 millimeters; angling thetubular punch to a second angle with respect to the surface of the skin,wherein the second angle is substantially equal to the angle of hairgrowth; and penetrating the skin to a second depth of between about 2.0millimeters and 7.0 millimeters while maintaining the tubular punch atthe second angle with respect to the surface of the skin and whilemaintaining the hair follicle within an interior space of the tubularpunch; and removing the hair follicle from the skin.
 39. A methodaccording to claim 38 wherein said first angle is about 90 degrees andwherein said second angle is about 56 degrees.
 40. A method according toclaim 38 further comprising applying a vacuum source to an end of saidtubular punch.
 41. A method according to claim 38 further comprising;moving the tubular punch in one or more of the following ways; rotating,oscillating or reciprocating or some combination thereof as the tabularpunch is being inserted to the first depth.
 42. A method according toclaim 38 further comprising; moving the tubular punch in one or more ofthe following ways; rotating, oscillating or reciprocating or somecombination thereof as the tubular punch is being inserted to the seconddepth.
 43. A method according to claim 38 further comprising; treatingan incision site with antibiotic ointment and a topical steroid.
 44. Amethod according to claim 38 further comprising; treating an incisionsite with antibiotic ointment post-surgically.
 45. A method of hairfollicle extraction comprising aligning an angled cutting end of atubular punch with the skin.
 46. A method of hair follicle extractioncomprising: contacting a surface d skin at a first angle with respect tothe surface of the skin using a tubular punch; making a first incisionabout a hair follicle into the surface of skin using the tubular punch;penetrating the skin with the tubular punch to a first depth of betweenabout 0.05 millimeters and 0.3 millimeters; angling the tubular punch toa second angle with respect to the surface of the skin, wherein thesecond angle is substantially equal to the angle of hair growth; andpenetrating the skin to a second depth of between about 2.0 millimetersand 7.0 millimeters while maintaining the tubular punch at the secondangle with respect to the surface of the skin and while maintaining thehair follicle within an interior space of the tubular punch; andremoving the hair follicle from the skin.
 47. A method of hair follicleextraction according to claim 46 wherein said first angle is about 90degrees and wherein said second angle is about 56 degrees.
 48. A methodof hair follicle extraction according to claim 46 further comprisingapplying a vacuum, to an end of said tubular punch.
 49. A method of hairfollicle extraction according to claim 46 further comprising; moving thetubular punch in one or more of the following ways; rotating,oscillating or reciprocating or some combination thereof as the tubularpunch is being inserted to the first depth.
 50. A method of hairfollicle extraction according to claim 46 further comprising; moving thetubular punch in one or more of the following ways, rotating,oscillating or reciprocating or some combination thereof as the tubularpunch is being inserted to the second depth.
 51. A method of follicularextraction to minimizing scarring comprising: contacting a surface ofskin at a first angle with respect to the surface of the skin using atubular punch; making a first incision about a hair follicle into thesurface of skin using the tubular punch; penetrating the skin with thetubular punch to a first depth of between about 0.05 millimeters and,0.3 millimeters; angling the tubular punch two a second angle withrespect to the surface of the skins wherein the second angle issubstantially equal to the angle of hair growth; and penetrating theskin to a second depth of between about 2.0 millimeters and 7.0millimeters while maintaining the tubular punch at the second angle withrespect to the surface of the skin and while maintaining the hairfollicle within an interior space of the tubular punch; removing thehair follicle from the skin; and treating an incision site withantibiotic ointment.
 52. A method of follicular extraction to minimizingscarring comprising: contacting a surface of skin at a first angle withrespect to the surface of the skin using a tubular punch; making a firstincision about a hair follicle into the surface of skin using thetubular punch; penetrating the skin with the tubular punch to a firstdepth of between about 0.05 millimeters and 0.3 millimeters; angling thetubular punch two a second angle with respect to the surface of theskin, wherein the second angle is substantially equal to the angle ofhair growth; and penetrating the skin to a second depth of between about2.0 millimeters and 7.0 millimeters while maintaining the tubular punchat the second angle with respect to the surface of the skin and whilemaintaining the hair follicle within an interior space of the tubularpunch; removing the hair follicle from the skin; and treating anincision site with a topical steroid.
 53. A method of follicularextraction to minimizing scarring comprising: contacting a surface ofskin at a first angle with respect to the surface of the skin using atubular punch; making a first incision about a hair follicle into thesurface of skin using the tubular punch; penetrating the skin with thetubular punch to a first depth of between about 3.05 millimeters and 0.3millimeters; angling the tubular punch two a second angle with respectto the surface of the skin, wherein the second angle is substantiallyequal to the angle of hair growth; and penetrating the skin to a seconddepth of between about 2.0 millimeters and 7.0 millimeters whilemaintaining the tubular punch at the second angle with respect to thesurface of the skin and while maintaining the hair follicle within aninterior space of the tubular punch; removing the hair follicle from theskin; and treating an incision site with a topical steroid at least 2days after incision.
 54. A method of follicular extraction to minimizingscarring comprising: treating an incision site with a surgicallubricant; contacting a surface of skin at a first angle with respect tothe surface of the skin using a tubular punch; making a first incisionabout a hair follicle into the surface of skin using the tubular punch;penetrating the skin with the tubular punch to a first depth of betweenabout 0.05 millimeters and 0.3 millimeters;